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The Performance of the APPY1 Test in the Evaluation of Possible Acute Appendicitis
NCT01652170 · View on ClinicalTrials.gov ↗
Study Summary
This study will consist of a brief interaction with the subject or parent or guardian to obtain consent, collect a blood sample, medical history, and physical examination of those who meet the inclusion criteria. The blood sample will be tested for the WBC value, as well as processed into plasma in order to compute the APPY1 Test result, which is based on a combination of the WBC value and the plasma MRP 8/14 and CRP concentrations received from the APPY1 Test cassette. There will be a 2-week (14 days +/- 3) follow-up telephone call for those subjects that were discharged from the ED without an appendectomy or diagnosis of acute appendicitis. Use of the APPY1 Test to help identify low risk patients could significantly reduce the use of CT scans in diagnosis of AA, thereby reducing the exposure to ionizing radiation in children, adolescents, and young adults.
Conditions Studied
Study Locations (20)
Massachusetts
- Newton-Wellesley Hospital — Newton
- Baystate Medical Center — Springfield
- South Shore Hospital — Weymouth
Ohio
- Cincinnati Children's Hospital — Cincinnati
- Cleveland Clinic — Cleveland
- Nationwide Children's — Columbus
Florida
- University of Florida, College of Medicine — Jacksonville
- All Children's Hospital — St. Petersburg
Georgia
- Emory-Egleston (CHOA) — Atlanta
- Scottish Rite (CHOA) — Atlanta
Michigan
- University of Michigan, Mott Children's Hospital — Ann Arbor
- Spectrum Health System — Grand Rapids
Arizona
- Phoenix Children's Hosptial — Phoenix
Arkansas
- Arkansas Children's Hospital — Little Rock
California
- UC Davis — Sacramento
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,201 participants |
| Start Date | 2013-01 |
| Est. Completion | 2014-02 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01652170
The ClinicalTrials.gov registry entry for NCT01652170 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2,201 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Venaxis, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Acute Appendicitis appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01652170 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Massachusetts, Ohio, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01652170 about?
NCT01652170 is a clinical study titled "The Performance of the APPY1 Test in the Evaluation of Possible Acute Appendicitis". This study will consist of a brief interaction with the subject or parent or guardian to obtain consent, collect a blood sample, medical history, and physical examination of those who meet the inclusion criteria. The blood sample will be tested for the WBC value, as well as processed into plasma in ...
What is the current status of trial NCT01652170?
This trial is currently completed. The enrollment target is 2,201 participants. The study started on 2013-01. Estimated completion is 2014-02.
What conditions does trial NCT01652170 study?
This clinical trial studies the following conditions: Acute Appendicitis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT01652170?
This trial is sponsored by Venaxis, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01652170 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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